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Scalable
Precise
Innovative
NxGen simplifies and accelerates genetic medicine development by enabling all scales through one single mixing element.
NxGen achieves this unique scalability by preserving the critical conditions at the point of formulation regardless of whether the throughput is mL/min or L/hour.
Scalable
The only technology that can scale a single mixer from mL/min to L/h.
precise
Time-invariant particle formation to ensure the most reproducible results for a wide range of particle types.
Innovative
This technology was developed exclusively by PNI.
The Evolution of Microfluidic Genetic Medicine Production
The proprietary NxGen microfluidic mixer at the heart of NanoAssemblr systems is designed specifically for genetic medicine development. Our Classic (formerly known as SHM) mixer was developed to address issues of reproducibility with scale-up achieved by scale-out of parallel mixers. NxGen, however, is uniquely capable of more than 25x throughput of our Classic mixer while maintaining the signature particle formation conditions that ensure the most reproducible results for a wide range of particle types.
The NxGen mixer enables the reproducible scale-up of mRNA Lipid Nanoparticles and other complex nanomedicine formulations
- Test batches of up to 12 L/h produced with a single NxGen mixer
- Particle characteristics (size and PDI) are constant
- Biological activity maintained
NxGen Microfluidic Technology Powering Genetic Medicine
NxGen Mixer Manufactures Equivalent mRNA-LNP when Compared to the Classic Mixer
| Classic: | NxGen: |
 |  |
| Mixer | Flow Rate (mL/min) | Size (nm) | PDI | mRNA Encap. (%) |
| Classic | 12 | 85 | 0.13 | 98 |
| NXGen | 200 | 90 | 0.10 | 98 |
In vivo performance of mRNA-LNPs were equivalent when made with Classic or NxGen
Further Details
LNPs loaded with luciferase mRNA were formulated using Classic or NxGen Mixers. Mice were injected IV with one of 3 doses and were injected IP with luciferin 6 hours later. Mice were imaged for bioluminescence as a reporter for gene expression. Significance (p<0.05) determined by unpaired t-test.
Challenging Formulation Scaled Up Through NxGen Technology
NxGen maintains the same conditions as manufacturing through all stages of development while increasing throughput with a single mixer.
Size and PDI of POPC/Chol Liposomes Maintained Across NanoAssemblr Platform
Develop a Diverse Range of Formulations
Polymer nanoparticles, liposomes and nucleic acid lipid nanoparticles (LNPs) can be optimized.
For example:
(A) PLGA nanoparticles were optimized by systematically varying the initial polymer concentration. PLGA was dissolved in acetonitrile and mixed at a Flow Rate Ratio of 1:1 with water containing 2% PVA.
(B) Liposome formulations were optimized by systematically varying the Flow Rate Ratio. Lipids were dissolved in ethanol and mixed at different Flow Rate Ratios with PBS buffer.
Statistically equivalent results were obtained between Classic and NxGen configurations at the bench scale.
A) Optimize Polymer Nanoparticle Formulations
B) Optimize Liposome Formulations
NxGen Technology Throughout NanoAssemblr Platform
Advanced Technology for
Advanced Genetic Medicines
NxGen technology preserves non-turbulent mixing conditions to provide unparalleled control over nanoparticle assembly that is scalable from discovery to the clinic.
1
An aqueous phase and a miscible solvent containing dissolved nanoparticle precursors are injected into each inlet of the NanoAssemblr cartridge2
Under laminar flow, the two phases do not immediately mix3
Microscopic features engineered into the channel reproducibly control the mixing of the two streams4
Rapid, controlled, homogenous mixing produces homogeneous nanoparticles
Resource Center
Application Note
March 15, 2022
Publication - Abstract
February 20, 2020
Nature Communications
Publication - Summary
April 04, 2019
The Journal of Neuroscience
Application Note
January 16, 2019
Publication - Abstract
November 01, 2018
Neuron